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. 2018 Sep 14;14(12):2848–2863. doi: 10.1080/21645515.2018.1502126

Table 1B.

Milk oral immunotherapy.

Study Food allergen N Age Range Study design Maintenance Dose Desensitization Outcome Long-term results Adverse events
Meglio et al. 200850 Meglio et al. 200466 Fluid milk 21 5–10 years Open-label, not controlled. Up to 200 mL milk or milk-containing foods 71% (15/21) tolerated 200 mL, 14% (3/21) reached 40–80 mL. Mean duration 201 days (range 183–234 days). After 48–51 months, 70% in follow-up (14/20) tolerating some milk. 43% (9/14) taking milk ad lib. Desensitization: 3/21 (14%) had mild symptoms so discontinued; 3/21 (14%) had symptoms so took a lower daily dose. Follow-up: no reactions requiring epinephrine.
Pajno et al. 201367 Fluid milk 32 4–13 years RCT, open-label, comparison of maintenance regimens. 150–200 mL daily (group A) or twice weekly (group B) and milk ad lib 100% in both groups continued maintenance, a similar frequency of allergic symptoms. N/A 8/15 in group A and 9/15 in group B had recorded events.
Salmivesi et al. 201368
Paassilta et al. 201669
Fluid milk 24 6–14 years (from initial study 2013) RCT, placebo control, double-blind, open-label crossover. 200 mL (6400 mg) daily 89% (16/18) OIT desensitized, not assessed in placebo. 100% (10/10) control patients desensitized in the crossover to open-label OIT. At 12 months, 13/18 (72%) of OIT taking 6400 mg CM daily. At 3 years, 85% OIT (including original OIT and crossover) tolerating milk daily, 58% at 7 years. Desensitization: 100% of OIT, 80% crossover, 63% of placebo patients reported symptoms. 6–12 months maintenance: 62% had symptoms, none severe; 50% at 3 years, 19% at 7 years.
Longo et al. 200852 Fluid milk, then foods with milk. 60 5–17 years RCT, open-label, (OIT/milk-free diet). 150 mL (4800 mg) then milk containing foods At 1 year, 37% (11/30) OIT fully desensitized to 150 ml daily, 53% (16/30) OIT partially (5–15), 0 % control passed DBPCFC. N/A Desensitization: 4 patients required IM epinephrine. Home dosing: 2 needed epinephrine. 20% control had an adverse reaction to accidental milk.
Morisset et al. 200751 Fluid milk. 57 1–6 years RCT, open-label (OIT/milk-free diet). After 6 months, 11% OIT and 40% control had positive SBPCFC (< 200 mL). N/A Reactions in 3 OIT, 0 control patients.
Martorell et al. 201170 Fluid milk. 60 2–3.5 years RCT, open label. (OIT/milk-free diet). 200 mL (6400 mg) daily At 1 year, 90% milk OIT tolerant to 200 mL daily, 13% (3/23) of control passed DBPCFC. RR 7.7 for milk tolerance in OIT vs. placebo. N/A 80% OIT patients had ?1 reaction, all mild-moderate. Reactions with 15% (114/738) doses.
Skpirak et al. 200853 Narisety et al. 200971 Keet et al. 201372 Milk powder. 20 6–21 years RCT, placebo controlled, double blind, then open-label crossover. (2:1 OIT/placebo) 500 mg daily for 13 weeks, then 7000 mg (if pass 8g DBPFC). 23% OIT, 0 % placebo, 67% crossover OIT passed DBPCFC (8000 mg); 92% active OIT, 0% placebo, 83% of cross-over OIT tolerant to ?2540 mg. At 5 years: 19% of 13 in follow-up tolerating unlimited milk, 31% 1 serving/day, 34% limited amounts, 16% no milk/avoiding completely. Desensitization: reactions to 45% of 2437 doses in OIT, 11% of 1193 in placebo patients. 4 patients required epinephrine. Follow-up open-label OIT: reactions in 17% of 2465 home doses.
Goldberg et al. 201565 Baked milk. 15 6–12 years Open-label, uncontrolled. Baked milk products daily as tolerated. 21% tolerated 1.3 g baked milk OFC. Maximum tolerated dose 900 mg unheated milk. N/A 8/15 did not complete desensitization due to IgE-mediated reactions. 2 had anaphylaxis requiring epinephrine with home doses.